Pfizer launches virtual clinical trial

The giant drug company Pfizer is conducting a “virtual” clinical trial that relies solely on electronic rather than face to face encounters between researchers and participants. It announced the trial on 7 June at a conference on clinical trials held on the Bethesda, Maryland, campus of the US National Institutes of Health.

Freda Lewis-Hall, Pfizer’s chief medical officer, said that the company is trying to reduce barriers to participation in clinical trials; to offer a consistently strong experience that does not vary by location; and potentially to save money in conducting trials in the future, if the concept proves viable.

Surveys of patients show that the time and effort needed to visit a trial site even within the same city, often many times on a fixed schedule, can make them less willing to participate in a study. Patients are more willing to make the effort if they face a life threatening condition and treatment options are limited but not as willing when the situation is less dire.

The study is using an already approved drug for bladder control in what Dr Lewis-Hall called an operation study to test concepts and tools. The results will be compared with those of already completed studies.

Web based and mobile phone applications (“apps”) are being used to manage recruitment, enrolment, and data reporting. Blood tests can be scheduled electronically either at a neighbourhood clinic or by appointment with a visiting nurse. The treatment drug is shipped directly to the patient. Help from doctors is available 24 hours a day, seven days a week by phone from a central location.

The study has begun in California and will roll out to nine other US states when necessary permissions have been obtained.

Dr Lewis-Hall told the BMJ that studies that involve patients’ self reports are especially amenable to a virtual method. “And this is a disease that is managed primarily by the patients within their own environment. So we thought it was a good therapeutic area [to test the concept],” she said.

An adviser to the study, Craig Lipset, said it will be interesting to see whether the diary-like apps for self reporting, the automatic reminders built into the system, and the freedom to take part at any hour of the day or night rather than at the convenience of the researcher will result in data entries that are closer to real time and hence more accurate than responses that are based more on distant recall.

Earlier at the conference Robert Califf, a professor at Duke University, Durham, North Carolina, and an expert on the clinical trials process, criticised the inefficiencies of some trials. A trial site that recruits only two patients a year increases costs and is unlikely to deliver the same quality of experience for the participants.

He said that regulatory burdens and costs are important reasons why “even the NIH [National Institutes of Health] is off-shoring a very large proportion of its clinical trials simply because it cannot be done in the United States.” Innovation might turn that around, he said.

Notes

Cite this as:BMJ 2011;342:d3722

Footnotes

bmj.com Feature: Get randomised! How can we solve the problem of low recruitment? (BMJ 2011;342:d3662, doi:10.1136/bmj.d3662)